Acor­da gets a bad­ly need­ed PDU­FA date with the FDA on Parkin­son's drug; Take­da signs neu­ro­log­i­cal col­lab­o­ra­tion with an­ti­sense play­er Wave Life Sci­ences

Acor­da $ACOR says that the FDA has fi­nal­ly ac­cept­ed their ap­pli­ca­tion for In­bri­ja (CVT-301), putting their in­haled form of lev­odopa for Parkin­son’s on track for a mar­ket­ing de­ci­sion by Oc­to­ber 5. The reg­u­la­to­ry ad­vance comes 6 months af­ter the agency ini­tial­ly re­fused to file their ap­pli­ca­tion, which now leaves the FDA due to make a de­ci­sion by Oc­to­ber. That’s a big deal at Acor­da, as its last re­main­ing patent pro­tect­ing its big drug Ampyra is set to ex­pire this sum­mer, leav­ing them stripped of any le­gal ar­mor against the gener­ics that will shred that mar­ket. Acor­da re­lies on Ampyra for al­most all of its rev­enue.

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